tDCS to Enhance Cognitive Training in Multiple Sclerosis (REHACOG-MS)

University of Milano Bicocca

Status: Withdrawn

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Device: Sham tDCS + CCT; Device: Real tDCS + CCT

Study type: Interventional

Funder types: Other

Identifiers

NCT04261556

REHACOG-MS

Details and patient eligibility

About

Expected results: an improvement in cognitive performance in both groups, boosted in the experimental arm and not confined to general frontal-cognitive abilities; potential changes would be reflected also by neurophysiological measures and in QoL.

Discussion: Investigators hope to provide additional treatment tools for RRMS subjects, with a medium-long term efficacy and an extensive effect. This exploratory pilot study will help to set the rationale for future studies, providing preliminary data useful for selecting the best primary outcome and for calculating a better sample size.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with clinically definite diagnosis of relapsing remitting MS (RRMS);
• Male or female subjects, 18 to 65 years old;
• Expanded Disability Status Scale (EDSS) score ranging from 0 to 5.5 (included);
• Predominant deficits in either attention/information processing;
• Fluent Italian speakers;
• Normal or corrected-to-normal vision;
• Ability to understand the purpose and risk of the study and provide signed informed consent.

Exclusion criteria

• MS patients in different phase of the disease (as primary/secondary progressive MS; benign MS) or Clinical Isolated Syndrome (CIS) patients;
• Exclusive cognitive impairment in different domains (e.g., memory);
• CT/neuromodulation program ongoing or in the preceding 6 months;
• Clinical exacerbations, neuroradiological activity of the disease, modification of EDSS score and disease modifying treatments/steroids during the last 3 months preceding study enrolment;
• Significant medical disorders or other major systemic, psychiatric, neurological disorders or alcohol/substance abuse that could interfere with cognitive functioning;
• Antidepressant/psychoactive drugs in the past 3 months;
• Contraindications to tDCS (intracranial metallic plates, implanted devices, skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, pregnancy, etc).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Real tDCS + CCT

Experimental group

Description:

40 min/day of computerised cognitive training (CCT) + 20 min/day of real anodal transcranial direct current stimulation (tDCS). In the first 20 min of the 40 min-intervention, tDCS and CCT will be provided simultaneously.

Treatment:

Device: Real tDCS + CCT

Sham tDCS + CCT

Sham Comparator group

Description:

40 min/day of CCT + 20 min/day of apparent (sham) tDCS. In the first 20 min of the 40 min-intervention, tDCS and CCT will be provided simultaneously.

Treatment:

Device: Sham tDCS + CCT